The following data is part of a premarket notification filed by Hunan Handlike Minimally Invasive Surgery Co., Ltd with the FDA for Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument.
| Device ID | K171825 |
| 510k Number | K171825 |
| Device Name: | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Hunan Handlike Minimally Invasive Surgery Co., Ltd A4, Lugu Yuyuan, #27, Wenxuan Rd High-tech Zone Changsha, CN |
| Contact | Hu Hanhan |
| Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2018-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EAI0818 | K171825 | 000 |
| EAI0788 | K171825 | 000 |
| EAI0787 | K171825 | 000 |
| EAI0786 | K171825 | 000 |
| EAI0785 | K171825 | 000 |
| EAI0784 | K171825 | 000 |
| EAI0783 | K171825 | 000 |
| EAI0782 | K171825 | 000 |
| EAI0781 | K171825 | 000 |
| EAI0780 | K171825 | 000 |
| EAI0779 | K171825 | 000 |
| EAI0778 | K171825 | 000 |
| EAI0792 | K171825 | 000 |
| EAI0793 | K171825 | 000 |
| EAI0794 | K171825 | 000 |
| EAI0817 | K171825 | 000 |
| EAI0816 | K171825 | 000 |
| EAI0815 | K171825 | 000 |
| EAI0814 | K171825 | 000 |
| EAI0813 | K171825 | 000 |
| EAI0812 | K171825 | 000 |
| EAI0811 | K171825 | 000 |
| EAI0810 | K171825 | 000 |
| EAI0809 | K171825 | 000 |
| EAI0808 | K171825 | 000 |
| EAI0807 | K171825 | 000 |
| EAI0777 | K171825 | 000 |